Dental Implant Healing With TNF-Alpha Inhibitors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
The goal of this pilot study is to learn about healing after dental implant placement in patients taking a class of biologic drug called Tumor Necrosis Factor or TNF-alpha antagonist or inhibitor. The main questions it aims to answer are:
Do patients taking TNF-alpha inhibitors have any complications after the placement of dental implants? Do patients taking TNF-alpha inhibitor experience increased pain after dental implant placement compared to the expected levels when healing from this procedure? Researchers will recruit patients both taking these drugs and those not taking these drugs to compare the outcomes between the two groups.
Participants missing teeth will be recruited to receive dental implants to meet ideal dental status and will be followed before and after the implant placement to determine levels of health and ensure proper healing. Participants will be followed for a total of one year and follow up visits will consist of both clinical examination and radiographs (x-rays) to evaluate bone level and implant status. Participants will also be asked to rate their pain during clinic visits and at home on a diary and record the amount of pain control medication they take after the implant procedure.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Over the age of 18
Require placement of implants to assist with dental restoration.
Half of the patients (15) will be recruited with the key criteria of a TNF-alpha inhibitor medication that they have been taking consistently without dose adjustment or other changes for at least 6 months. The other half will be recruited without a target medical condition but will be recruited to match the patients taking TNF-alpha inhibitors in age and gender.
All patients will be medically fit to withstand implant placement as judged by best practice applied by the study team.
Disqualifiers
They have periodontal disease (periodontal pockets above 4mm in the applicable arch or radiographic evidence of horizontal bone loss more than mild severity)
There is other evidence of pathology in the treated arch on pre-treatment review including radiographs, such as any evidence of cyst or tumor formation in the mandible.
They have uncontrolled diabetes (HbA1c >8.0) as confirmed by evaluating labs taken on anyone with diagnosed diabetes in the 6 months before the study enrollment.
They have history of head and neck radiation for any reason
Trial design
Design model
Parallel
Treatments tested in this trial
Placement of dental implants
Procedure/SurgeryDental implants will be placed in the edentulous area as per standard surgical procedure and as appropriate to bring the patient to standard of care restoratively.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Patients taking TNF-alpha inhibitorsExperimental treatment 1 intervention
Group B: Patients not taking TNF-alpha inhibitorsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of implant placement in patients taking TNF-α inhibitors
A pilot cohort of patients will be recruited who require implants for standard of care restoration for tooth loss. Patients will be evaluated pre- and post-operatively and followed for 1 year to assess healing using clinical exam.
Time frame
Healing will be assessed over 1 year after implant placementSecondary outcomes
1
Patient pain after implant placement in patients receiving TNF-alpha inhibitors using patient rating scales
While no previous dental research has directly evaluated perception of healing in patients taking TNF-α inhibitors, previous evidence points to an increase in pain during surgical healing in patients taking BAs. Patient discomfort will be measured by visual analog (VAS) patient rating scales as are widely used after dental surgery. The VAS scale from 0 to 10 where 0 means no pain and 10 means the worst possible pain will be used. Applying these outcomes to implant healing in patients taking TNF-α inhibitors will provide an assessment of patient experience. We hypothesize that there will be an increase in pain ratings compared to established expectations. This is the first study to evaluate patient discomfort after implant placement in patients taking BAs and the first prospective study of patients taking BAs in dental medicine and thus will add to the literature by characterizing healing and patient experience.
Time frame
This will be assessed during the pre-surgical appointment to understand patient baseline and after surgery daily for the first week and then at 1 week, 1,3,6,and 12 months.2
Patient pain after implant placement in patients receiving TNF-alpha inhibitors using analgesic use
While no previous dental research has directly evaluated perception of healing in patients taking TNF-α inhibitors, previous evidence points to an increase in pain during surgical healing in patients taking BAs. Patient discomfort as measured by analgesic use in number and timing of doses taken will be evaluated. Extrapolating these outcomes to implant healing in patients taking TNF-α inhibitors will provide an assessment of patient experience. We hypothesize that there will be an increase in analgesic need compared to established expectations, to be further evaluated according to additional factors, if present, at further study. This is the first study to evaluate patient discomfort after implant placement in patients taking BAs and the first prospective study of patients taking BAs in dental medicine and thus will add to the literature by characterizing healing and patient experience.
Time frame
This will be assessed during the pre-surgical appointment to understand patient baseline and after surgery daily for the first week and then at 1 week, 1,3,6,and 12 months.Other outcomes
1
Systemic levels of inflammatory markers
We will also perform exploratory analyses of whether systemic inflammation, as assessed by systemic blood markers (CRP, ESR, CBC, and cytokine measurements), is associated with implant healing, peri-implantitis, or discomfort after implant placement.
Time frame
Blood will be drawn for lab tests at implant visit and at follow up visits (1 week, 1 month, 3 month, 6 month, 12 month) to trend values.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
Nobel Biocare
Collaborator
Source ClinicalTrials.gov